OVERVIEW:

This role is responsible for providing technical engineering support to new product development teams and sustaining manufacturing/operation teams. This individual will be expected to apply knowledge of design control principles and quality engineering techniques to identify risks in design, facilitate transfer, and promote design for manufacturability and ease of maintenance. As a member of one or more cross-functional teams, he/she will interface with manufacturing and vendors to mitigate risks throughout the product life cycle. In parallel, this person shall ensure the products are developed in accordance with applicable regulatory requirements, customer expectations and industry standards.

RESPONSIBILITIES:

  • Collaborate with product design/development engineering, regulatory, clinical, marketing, and other organizational partners to assure appropriate quality requirements are defined and conveyed throughout the supply chain

  • Ensure FMEA’s are performed as required to mitigate risks in design, transfer, and manufacturing

  • Support development, implementation and maintenance of Design Verification & Validation (V&V) methodologies and best practices to impact product launch timeliness, improve implementation of design enhancements and reduce number of design iterations

  • Work with product design/development teams and manufacturing operations to translate design requirements into manufacturing requirements to increase manufacturability, reduce scrap and improve operational efficiencies

  • Support DMR and DHF compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained

  • Lead the development, validation and implementation of inspection and test methods (including training of inspection and test personnel)

  • Lead cross functional teams to implement risk assessment and risk management processes

  • Provide documentation to support regulatory submission activities and review content for compliance to QSR regulations

  • Participate in cross functional teams to review and evaluate impact of proposed supplier changes

  • Provide support to complaint management and post market surveillance organization by completing robust and timely complaint investigations

  • Develop, coordinate and perform technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE)

  • Develop statistical process control methodologies to achieve required levels of product reliability

  • Analyze quality performance indicator data and investigate adverse trends to identify variables that may potentially affect product and processes

  • Identify opportunities to implement design changes to improve system and/or process reliability, reduce scrap rates and improve yields and efficiencies

  • Serve as Subject Matter Expert for regulatory inspections related to Design Controls, Process Validation, Device Master Records and Design History Files

QUALIFICATIONS:

  •  BS Degree in Mechanical, Electrical or Biomedical Engineering

  • 10+ years engineering experience.

  • 5+ years Class II or Class III medical device experience.

  • Significant experience working with new product design/development projects or sustaining engineering projects

  • Experience in complying with Design Controls and mentoring other organizations regarding Design Control requirements and expectations

  • Demonstrated knowledge of FDA Quality System Regulation, ISO 13485 Quality Management System and ISO 14971 Risk Management for Medical Devices.

  • Strong organizational skills and ability to prioritize workflow to meet established time frames and schedules

  • Able to constructively collaborate with cross-functional teams

  • Experience with injection molded components, including; Mold Qualification, First Article Inspection Process Validation and Process Controls are desirable.

  • Experience with electro-mechanical devices including electrical safety testing.

  • Process validation expertise related to manual assembly processes.

  • ASQ Certification (Certified Quality Engineer, Certified Quality Manager) a plus.

  • Demonstrated ability to act as Subject Matter Expert related to Design Controls, Device History Files, Master Validation Plans, DFMEAs and PFMEAs

  • Experience supporting regulatory agency inspections and Notified Body Audits in an SME role

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